Medical Device QMS Audit Manager

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November 1

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SGS

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Compliance • SaaS • Sustainability

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

10,000+ employees

Founded 1878

📋 Compliance

☁️ SaaS

📋 Description

• Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical) • Approve Level 1 audits and witness audits for auditor qualification and requalification • Develop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance • Ensure competence, compliance, and operational efficiency across assessment teams • Provide technical support across SGS NB 1639 activities and contribute to business development

🎯 Requirements

• 10+ years in the medical device industry • At least 5 years in R&D or manufacturing roles • Minimum 4 years working within a Notified Body • Minimum 2 years leadership experience • Prior qualification as a Lead Auditor under MDR and/or IVDR • Deep technical knowledge of non-clinical aspects of medical device conformity assessment • Strong understanding of EU regulatory frameworks and best practice guidance

🏖️ Benefits

• Competitive salary • Collaborative and inclusive work environment • Opportunities for professional growth and development